Individuals engaged in human subjects research must be qualified with the appropriate education, expertise, and credentials to conduct human research.
Individuals included on the research personnel list must be UC Davis faculty, employees, students, volunteers, or outside collaborators working under the oversight of the UC Davis Principal Investigator and covered by an Individual Investigator Agreement. Contact the IRB if you have questions regarding research personnel.
All research personnel are required to complete human subject research protection training prior to engaging in research activities.
In This Section
- Research Personnel List
- Who is Considered Research Personnel?
- Engagement Determination
- Changes in Research Personnel
On the Additional Personnel page of the Initial Review Application, you will be asked if there are any additional personnel for this study? You will add each person who is part of the research personnel here. This is the research personnel list. When making changes to research personnel, you will edit the Initial Review Application to add or remove personnel from the list.
Research personnel include all individuals who are “engaged” in human subjects research.
Personnel are “engaged” in human subjects research and must be listed as research personnel if they will:
- intervene with subjects to collect data or biospecimens about them by performing research procedures, or by manipulating the environment for research purposes;
- conduct the informed consent process;
- collect or create identifiable, private information about subjects; or have access to identifiable private information about research subjects.
Personnel are “not engaged” in human subjects research and are not required to be listed as research personnel if they will:
- receive ONLY deidentified biospecimens or data
- access identifiable data for auditing or monitoring
- facilitate recruitment by informing potential subjects about research or sharing recruitment materials
- perform commercial services for investigators when (1) services performed do not merit professional recognition or publication privileges, (2) services performed are typically performed by those institutions/individuals for non-research purposes; and (3) the individuals do not administer the study intervention being tested or evaluated under the protocol
- perform protocol-dictated services/procedures which would be typically performed as part of routine clinical monitoring or follow-up. [Read Guidance B(2) before making this determination]
- administer study interventions being evaluated under the protocol on a one-time or short-term basis [Read Guidance B(3) before making this determination
Hospital staff, including nurses, residents, or fellows and office staff who provide ancillary or intermittent care but who do NOT make a direct and significant contribution to the data are not considered research personnel and do not require training. It is not necessary to include in your research personnel list a person with only an occasional role in the conduct of the research, e.g., an on-call physician who temporarily dealt with a possible adverse event or a temporary substitute for any research staff. If it is unclear whether certain hospital staff is “engaged” and therefore require training, please contact the UCD IRB Administration for guidance.
Updates to research personnel, unless it is a change of PI or Co-PI, are not required to be submitted to the IRB as a Modification. Please keep records of your personnel changes and submit the current personnel list at Continuing Review. The PI is responsible for ensuring that all research personnel have completed the required training prior to engaging in research activities. If the research does not require continuing review, then you will not submit any changes to the personnel list to the IRB.
When making changes to research personnel, you will edit the Initial Review Application to add or remove personnel from the list.